The present invention relates generally to hemostatic devices and more particularly to an insertion assembly and hemostatic closure device which are insertable into an incision or puncture formed in the body of a patient to seal the incision from the flow of body fluids therethrough.
During catheterization or other medical procedures, a physician will create an opening into an artery or other blood vessel of a patient with a conventional catheter introducer or dilator. The size of the opening will vary depending on the type of procedure and the size of the catheter which is to be used. For example, the diameter of the catheter and catheter sheath used in standard angiography procedures is typically between 5 to 8 French (1.67 mm and 2.67 mm, respectively). The diameter of the catheter and catheter sheath used in angioplasty procedures and an increasing number of stent placement procedures may be about 8 (2.67 mm) or 9 (3.33 mm) French. The diameter of the catheter and catheter sheath used in intro-aortic balloon pump procedures is typically between 14 to 16 French (4.67 mm and 5.33 mm, respectively) and the diameter of the catheter and catheter sheath used with cardiopulmonary support systems is typically between 18 and 20 French (6.0 mm and 6.67 mm, respectively). Additionally, the catheter may often be twisted or otherwise manipulated as it is advanced to the treatment site, thereby causing a further enlargement of the incision or puncture in the body of the patient.
When the medical procedure is completed and the catheter is removed from the artery or other blood vessel, the conventional practice has been to apply external pressure to the entry site until clotting occurs. Because many of the patients undergoing these procedures have been medicated with an anticoagulant such as heparin, the nurse may be required to apply external pressure to the incision site for an extended period of time. The time required to stop bleeding at the incision is not an efficient use of the nurses time and a painful hematoma or unsightly bruise may still occur at the incision site because the artery will continue to bleed internally until clotting blocks the opening in the artery.
U.S. Pat. No. 4,829,994 granted to Kurth on May 16, 1989, attempts to resolve the above-described problem by providing an apron-like device consisting of a pelvic apron and a groin strap to apply a compressive force to the femoral vessel of the patient. Although this device effectively eliminates the need to have a nurse apply direct pressure to the incision site, a decrease in blood flow through the femoral artery may be caused by the use of this device and may increase the likelihood of clot formation in the compromised patient.
Another approach to resolving the above-identified problem is disclosed in U.S. Pat. No. 4,929,246 granted to Sinofsky on May 29, 1990. The method of using the device disclosed in this patent includes the steps of advancing a semi-rigid tube having an inflatable balloon at its distal end through the overlying tissue to a location adjacent to the outer wall of the punctured artery. The balloon is then inflated to apply pressure directly to the outer wall of the artery. Laser energy is then directed to the outer wall of the artery via an optical fiber centrally located in the semi-rigid tube such that the laser energy passes through the optical fiber and balloon of the semi-rigid tube to thermally weld the artery and seal the incision.
A further approach to resolving the above-identified problems is disclosed in U.S. Pat. No. 4,744,364 granted to Kensey on May 17, 1988, and related U.S. Pat. Nos. 4,852,568 and 4,890,612 granted to Kensey on Aug. 1, 1989, and Jan. 2, 1990, respectively. The first two Kensey patents disclose a device for sealing an opening in the wall of a blood vessel which consists of an elongate tubular body having an expandable closure member removably disposed therein. The tubular body also includes an ejecting device disposed within the tubular body for forcing the closure member from the tubular body into the interior of the blood vessel. A retraction filament is secured to the closure member so that the engagement surface of the closure member hemostatically engages the inner surface of the blood vessel contiguous with the puncture. The ""612 Kensey patent discloses a device which includes an elongate absorbable member having a holding portion which is adapted to engage portions of the tissue adjacent to the punctured vessel or organ to hold the plug member in place and a sealing portion formed of a foam material which extends into the punctured vessel or organ to engage the tissue contiguous therewith to seal the puncture. Subsequent patents granted to Kensey et al. are illustrative of improvements to the basic approach described above and generally include an anchor member which is used in combination with a suture and a collagen member to seal an incision or blood vessel.
U.S. Pat. No. 5,108,421 granted to Fowler and assigned to the assignee of the present invention, discloses the use of a xe2x80x9cvessel plugxe2x80x9d type approach wherein the hemostatic closure device is inserted into the incision of the patient and may be positioned in the incision using a locating member such as an elongate balloon type member or a syringe type device. U.S. Pat. No. 5,391,183 granted to Janzen et al. discloses another vessel plug type approach wherein one or more hemostatic closure devices are inserted into the incision using a device with a plunger member. None of the prior art devices teach the use of a simple and relatively inexpensive means for reliably effecting the closure of a puncture or incision in the wall of a blood vessel, duct or organ to significantly reduce the time to ambulation of a patient as well as to reduce the risk of hematoma or clot formation.
Accordingly, it is an object of the present invention to provide a device and method of use which overcomes the disadvantages of the prior art.
It is another object of the present invention to reduce the time required for sealing an incision in an artery and to decrease the likelihood that a hematoma will form after the catheter is removed from the incision.
It is yet another object of the present invention to provide simple, reliable and easy to use device for locating the wall of a blood vessel, duct or organ using the locating device of the present invention.
These and other objects of the present invention are achieved by providing a device and method for sealing an incision in a blood vessel, duct or organ using the device as described hereinafter.
One form of the present invention preferably includes a sealing assembly consisting of a relatively small diameter locating device which is used in conjunction with a conventional access sheath. The locating device preferably includes one or more wire locating members thereon and a porous, absorbable hemostatic closure device. The hemostatic closure device includes a distal end which is preferably sized and shaped so that the distal end of the hemostatic closure device may be positioned generally along and proximally of the outer surface of the blood vessel duct or lumen so that the hemostatic closure device will not enter into the blood vessel and potentially cause a disruption in the flow of fluid past the incision. The method of using the preferred form of the present invention includes the steps of inserting the sealing assembly into the incision through an access sheath which has been previously used to perform the medical procedure and which is positioned to extend a short distance into the blood vessel of the patient. The sealing assembly is advanced in the access sheath until the locating members extend slightly beyond the distal end of the access sheath and in the blood vessel. The locating members on the distal end of the locating device are then positioned to extend laterally from the distal end of the locating device. The entire assembly including the sealing assembly and the access sheath is then withdrawn slightly in the incision and blood vessel until the locating members contact the distal side of the blood vessel wall. The access sheath is then removed from the incision to expose the hemostatic closure device to the blood and other fluids in the incision. This exposure of the hemostatic closure device to blood or other fluids allows the hemostatic closure device to absorb fluids in the incision and from the surrounding tissue while allowing the hemostatic closure device to expand in the incision. Finally, the locating members may be withdrawn from the incision without disturbing the position of the hemostatic closure device in the incision. A dressing may then be placed over the incision site to protect the incision while the hemostatic closure device is incorporated into the surrounding tissue.
An advantage of the present invention is that the hemostatic closure device does not extend into the blood vessel, duct or organ and therefore, the flow of fluid through the vessel is not obstructed by the hemostatic closure device.
Another advantage of the present invention is that locating device of the present invention may be used to reliably position the distal end of the hemostatic closure device generally along or proximally of the proximal surface of the wall of the blood vessel without significantly obstructing the blood vessel, duct or organ of the patient.
Yet another advantage of the present invention is that the locating members of the locating device of the present invention preferably extend around less than one half of the circumference of the hemostatic closure device and more preferably less than one fourth of the circumference of the hemostatic closure device.